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This study evaluates the long-term safety of Udenafil in Patient with Pulmonary Arterial Hypertension(PAH). All the patients will receive Udenafil for 1-year(48-weeks).
Pulmonary arterial Hypertension is characterized by a progressive incerease in pulmonary vascular resistance(PVR) leading to right ventricualar failure.
Udenafil inhibits PDE 5, an enzyme that metabolizes cGMP, enhancing the cGMP mediated relaxation and growth inhibition of vascular smooth muscle cells, including those in the lung.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Udenafil | Experimental | Udenafil 50mg tablet by mouth, every 12 hours for 1-year(48-weeks) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Udenafil | Drug | Udenafil 50mg tablet |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety (Adverse Events, Physical Examination, Vital Sign, Electrocardiography, Laboratory test, etc) | Adverse Events, Physical Examination, Vital Sign, Electrocardiography, Laboratory test, etc | during 48-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 6-MWD | 24, 48-week | |
| BORG dyspnea score | 24, 48-week | |
| WHO class |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| Duk-Kyung Kim, M.D., Ph.D. | Samsung Medical Center | Study Chair |
| Sung-A Jang, M.D., Ph.D. | Samsung Medical Center | Principal Investigator |
| Jun-Bin Park, M.D., Ph.D. | Seoul National University Hospital | Principal Investigator |
| Hyung-Kwan Kim, M.D., Ph.D. | Seoul National University Hospital | Principal Investigator |
| Hyuk-Jae Jang, M.D., Ph.D. | Severance Hospital | Principal Investigator |
| Hae-Ok Jung, M.D., Ph.D. | Seoul St. Mary's Hospital | Principal Investigator |
| Jung-Hyun Choi, M.D., Ph.D. | Pusan National University Hospital | Principal Investigator |
| Jae-Seung Lee, M.D., Ph.D. | Asan Medical Center | Principal Investigator |
| Kye-Hun Kim, M.D., Ph.D. | Chonnam National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | Gangnam-Gu, Irwon-Dong 50 | 135-710 | South Korea |
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| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C419664 | udenafil |
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| 12, 24, 36, 48-week |
| Time to clinical worsening(TTCW) | during 48-weeks |
| NT-pro BNP | 24, 48-week |
| Echocardiography | 48-week |
| Jin-Ok Jeong, M.D., Ph.D. |
| Chungnam National University Hospital |
| Principal Investigator |
| Sang-Yeub Lee, M.D., Ph.D. | Chungbuk National University Hospital | Principal Investigator |